29 July 2010

The effort, in Washington State, represents the most sweeping attempt yet to stem what some experts see as the excessive use of prescribed narcotics, and it is being closely watched by medical professionals elsewhere. Among other things, Washington would apparently become the first state to require a doctor to refer patients on escalating doses of pain killers for evaluation if they were not improving.

Experts in pain treatment and drug abuse prevention say the growing use of long-acting pain killers like OxyContin, fentanyl and methadone has been a crucial factor in a nationwide epidemic of overdose deaths, largely from the abuse of such drugs.

Drug makers and patient groups have complained that new restrictions would unfairly punish pain sufferers who rely on the drugs. Others, including some doctors and regulators, have argued that the drugs are potentially so dangerous that they need to be even more tightly controlled.

However, the Washington State initiative appears to reflect a growing view that the status-quo is no longer acceptable. Last Friday, an advisory panel to the Food and Drug Administration overwhelmingly rejected an agency proposal to better control drugs like OxyContin as too weak because it did not require special training for doctors who prescribe such medications.

The effort in Washington is also directed at controlling how doctors use narcotics to treat legitimate pain patients, not at people who illegally obtain the drugs for recreational use. While many patients benefit from pain killers, there is growing evidence from studies, including one in Washington State, that others suffer significant side effects, including lethargy, increased sensitivity to pain and, in the most severe instances, potentially fatal overdoses. [...]

The panel is expected to require that, among other things, doctors refer patients to a pain specialist for review when their daily medication increases to a specified dosage level and they do not show improvement. The specialist can then determine whether to continue the drug, reduce it or use other treatments like physical therapy.

Recently, the Centers for Disease Control issued a similar recommendation to doctors.

Pain specialists and regulators in Washington State said they thought the requirements were essential because doctors were giving high daily dosages of powerful drugs for ailments like back pain for far too long without evidence that the drugs worked.

The law that created the new regulatory effort in Washington State did not propose specific sanctions or penalties. However, officials there said that a doctor who chose to ignore the new rules could face sanctions from state licensing boards, including potentially losing the right to practice. The company that makes OxyContin, Purdue Pharma, lobbied against the law, saying the new regulations could deprive patients of appropriate treatment.

The initiative sprang out of the efforts of Dr. Cahana and two other people, including a Washington State representative, James C. Moeller, who is also a substance abuse counselor.

Mr. Moeller, who works at a facility in Vancouver, Wash., run by Kaiser Permanente, said he had treated a steady procession of patients in recent years, nearly all of them young and physically dependent or psychologically addicted to high dosages of pain killers.

In the process, Mr. Moeller said, he realized that many doctors who prescribed such drugs had little training in either pain management or substance abuse. So, wearing his legislator’s hat, he drafted a bill to require doctors to take a training course to prescribe narcotics.

He said he quickly encountered opposition to the idea from a professional group that represented doctors. [...]

“There is a dissonance in not recognizing the nexus between poor pain management and the hyperconsumption of opioids,” said Dr. Cahana, who works at the University of Washington Medical Center in Seattle, using a medical term for narcotic pain killers like OxyContin.

Dr. Franklin, whose department oversees the state’s workers’ compensation program, said he had long seen the problem play out among claimants. “Injured workers were coming into the system with low back pain and dying two or three years later” from drug overdoses, he said.

This year, Dr. Cahana and Dr. Franklin testified during a legislative hearing on the proposed training requirement, suggesting that legislation should instead require a set of medical practices based on the best available evidence. Dr. Franklin said that a draft of rules would probably be finished by this fall and that the new regulations would be in place by next year.

A major hurdle to making the program work is the lack of pain management specialists, particularly in rural areas of the state, where patients could be referred for evaluation. Dr. Franklin said the state hoped to increase the use of telephone consultations as well as help to finance the training of doctors in pain treatment.

I'm not sure what to think about this. I've been pretty appalled by the proliferation of narcotic super-users, people on what you might call "hyper-doses" of pain meds for chronic and incurable conditions. The most striking thing I have noticed is the high likelihood, when I see a patient on 160mg of oxycontin TID, is that it's not working, and they are still complaining of uncontrolled pain! I can concede that there is a selection bias in the ER and I am more likely to see people whose pain is uncontrolled by the nature of the setting. However, it is striking that the pain specialists seem to have a similar experience. I really think that it would be an overall social good if the wanton use (because it is in many cases wanton) of these medications by non-pain-specialists were reined in.

But. (You knew there was a but coming, right?)

It's inarguably true that there are not and will not be in the foreseeable future enough pain specialists to see all the people who might need this "referral." Medicaid patients (who are more likely to be on chronic pain medicines because there is a high correlation between chronic pain, disability and the poverty that qualifies one for medicaid) have it even worse since pain specialists are no more willing to see money-losing patients than any other office-based physician is.

There's a similar concern regarding the requirement for special training requirements for doctors to prescribe Oxys and the like, since my experience is that many primary care doctors are reluctant to take these course and might simply use it as a pretext to stop prescribing these drugs at all. So the effect might be that many patients, many who are appropriately treated, might simply get cut off.

It's a tough problem. I don't see an easy solution, or any solution without significant risks. But it is clear that the status quo is not acceptable and that something needs to be done.

Injury, problem with surgery, bad medical advice, delayed medical treatment caused my condition to get out of control, this caused my pain to be severe, but my case was treated of a average case, 12 years I had six weeks with good pain control and was making major improvement until my dosage was reduced because someone thought it was to much, since then May 2005 I have been in decline, had more surgeries and nearly died, I lose everything and my pain is much worse. I would have had a full recovery by 2006, now I will never recover, suicidal pain level no access to get pain under control. Drug rehab clinics on every corner, no where to go to get pain treated and under control, I know what works, what I need, yet I am tortured with acute pain that is easy to resolve, I'm going to die, this is murder! I am forced to die for simple medical issue, I am forced to pay for and accept improper medical treatment! CROOKS! KILLING ME! for money, no accountability, no one cares, until it's them, America what a country, the great people are gone, live with the crap.

There are several drugs that have training programs required prior to prescribing. Thalidomide for myeloma requires participating in Celgene's STEPS program. In 2007, FDAMA created REMS programs (Risk Evaluation and Mitigation Strategies), and one has recently been enacted for ESAs in cancer patients (Procrit, Aranesp). This REMS has a mandated eduction component. Before the drugs can be dispensed, the pharmacist has to ensure that the REMS requirements are met, which increases workload/oversight.

The FDA recently rejected creating a REMS for opiates. I don't believe that there was much controversy over the thalidomide program, but oncologists do not feel that they had sufficient input into development of the REMS for the ESAs. A REMS for opiates would be not only a burden on prescribers, but also a logistical nightmare for pharmacists.

I don't know what the answer is. My background is oncology pharmacy, so I always first worry about cancer patients losing access to important pain meds or having their pain under-treated whenever restrictions on opiate prescribing are discussed.

My personal experience with pain mgt docs can be summed up as legalized pill pushers. Inaccurate records and incomplete written pain contracts that don't cover the obvious need for opiates after surgery or in an ED setting. Pain docs assert their right to blame the patient for anything that goes wrong due to their own incompetence. There is a cure: Fire your pain doc and report anomalies in patient care and record keeping to the hospital administration and state medical board.

I favor the idea of guidelines. Frankly, a lot of the time I'm reluctant to increase narcotic dosages because although I may have my doubts about the patient's pain status (yeah, right; you need your oxys to play golf. Try yoga instead and see if we can't cut down the narcs) I don't have much of a leg to stand on when the patient says they hurt. If I had federal guidelines to shove in front of their noses, I think it would go a long way towards curbing the "patient demand" side of the equation.

I too hate to see things getting in the way of patients in pain getting the meds they need. However, if (ideal world) they could all be treated by competant pain specialists, hopefully their pain would be treated better.

Different opiooids work better for different people. If one isn't working, a good pain doc would try others, perhaps in combination, and try to find something that does work. For example, there are people (more men than women I've heard ancedotally) that do not respond to Dilaudid. Practically like giving water. Whereas some other meds work fine for them.

As far as high doses - some might find this interesting. Some people will respond, once the dose gets high enough:

http://www.medscape.com/viewarticle/714030

Cytochrome P450 Gene Implicated in Need for High-Dose Pain Medication

"December 17, 2009 (Los Angeles, California) — Genetic abnormalities in cytochrome P450 may cause some patients to metabolize opioids at an accelerated or retarded rate, prompting the need for higher doses of medication to control pain, according to a new research presented here at the American Academy of Addiction Psychiatry 20th Annual Meeting & Symposium.

Chronic pain patients who require high doses of opioids may lead clinicians to suspect them as possible addicts or abusers, but Forest Tennant, MD, lead author of the study and a physician with the Veract Intractable Pain Clinic in West Covina, California, said other factors are at play."

You are actually missing one of the real biggies and, if you ask me, one of the real ironies. Suboxone actually requires not only special training but a special DEA license in order to be prescribed (unless it is for pain and not for addiction). So to prescribe 160 mg of a schedule II like Oxycontin needs no special training but 2 mg of Suboxone, a schedule III, requires all sorts of hoops and oh by the way you can't treat more than 100 patients at a time (no more than 30 patients for the first year).

Now, I am not arguing for or against the proposal to require training, but I am saying it makes no sense that a much more dangerous drug that causes problems needs no training while a much, much safer drug that fixes those problems does.

After surgery on my lower back a few years ago my PCP suggested that I see a pain specialist, not because I was writhing around in his office day after day tripping over "that medicine that begins with a D," but because he wanted to ensure that ALL options of pain management were explored, not just the ones that involved doping me into oblivion; complete with a refill x3. My surgical recovery was progressing a bit slower than we had anticipated, and while on most days the discomfort was manageable using a combination of OTC medication and 80 mg tablets extended release "Tufinup" the thought was to explore some other strategies. I live in a relatively small city which meant referring me out of town.

My one and ONLY visit to the so-called specialist left me with that not-so-fresh feeling; as well as the compulsion to make a pact with anything (including things evil) that could assure the cleansing of my soul; eliminating the pure disgust I felt for having visited the office of Doctors Sate, Into, and Oblivion.

The office I visited would not bill insurance, and would not accept credit, debit, or check. Not surprisingly they preferred cash, and upon receiving payment the conveyor line model of treatment went into overdrive. Examination consisted of CYA opiate contracts (which appeared to have been written by someone with a painfully limited regard for just about every imperative found in English language) a check of BP, and a hop on and off a scale, and finally, a review of my PCP's notes and reason for referral.

The doctor then asked what generally worked for my pain. When I explained that I thought I was there to investigate some non-euphoric ways of dealing with pain, he actually laughed. At about the same time I noticed that the exam room had one light, and that it was putting out about 18 of darkness cutting energy. Adding to the creepiness of the place, it did not look like it had been cleaned since the Carter administration. It smelled like a combination of urine, a wet cat, and cheap pine-scented cleaner.

I was told that back injuries were bad, and that pain medicines were good. I was talked to like I was at least partially retarded and did little to shield him from my unmistakable growing sense of resentment. I was offered a two-week supply of (insert Narcotic here) but that I would have to return in two weeks time to receive more. And all of that was NOT so that I'd be charged a fee for additional visits (though I would have been) but rather to monitor and ensure compliance with the agreement I would need to sign.

At that point I let it slip that I did not think the situation was what my PCP had intended and that I thought it in my best interest to leave before I became part of the collateral damage of the DEA sting I was sure was going to go down at any moment.

I returned to my PCP and we began employing some different treatments (he knew I'd not soon return to pain specialist; at least not until we had tried some other treatments) and over the next few months, with conservative care, PT, and very limited medications, I began to feel much better.

The point of my unnecessarily long rant is that while I'm fully on board with the idea of pain specialists (at least in theory) no one is served by referrals to the type of d-bag narc pusher I encountered. I would also be remiss if I did not point a constant truth; that there are some great doctors out there, some incredibly measured and reasonable physicians who no doubt spend a lot of time helping people cope with life altering chronic pain. We owe a debt to those who do provide such services, and who do so with much more than a modicum of integrity and professionalism.

Nevertheless, I have had the same PCP for over five years, and I'd rather he never again Rx me a narcotic than for a rule to be adopted that forces him to refer me out to someone I do not know. I value my doctor and it has taken years of getting to know him (and him me) to develop trust and a mutual understanding as it relates to treatment, even when that treatment requires infrequent use of narcotic pain medication.

Farming out chronic pain sufferers to other physicians for purposes of pain management might work for some, but I have to wonder (with concern) about the potential for abuse, and a proliferation of the very problem such a measure would seek to limit.

I would just like to see some general common sense instructions given to patients when opiates are prescribed. Like take them for pain, not because you like how they make you feel.

I also think that increasing dosage needs can be warded off by giving yourself a daily drug holiday. Don't take any overnight. Dope yourself up on a muscle relaxer (and I don't mean Soma) to sleep and you've cleared the narcotic out of your system.

Patients come in the ER all the time stoned out of their gourds, barely able to maintain an adequate 02 sat, demanding more narcs. What they are looking for is that original high they felt when they first started taking narcotics. It is impossible no matter how much dope you take to feel that same euphoria that you used to feel before you developed a habit. Junkies call it "chasing the dragon". Its the elusive high.

It is interesting to me that Washington State is so full of pill-pushing doctors and patients who don't want narcotics. That's a lot different from SC where I am a pain physician and no where near enough doctors are willing to take the risk of prescribing narcotics and no shortage whatever of pill-seeking patients. Why this difference? I believe that doctors in my state have been frightened by threats of sanctions to the point that they are unwilling to do even the most reasonable things to treat pain. My personal perception that we have lots of drug-seekers likely is the result of the practice, now more and more widespread, of dumping even minor pain complaints on specialists such as me. This to avoid exposure of the referring physicians to the dreaded sanctions mentioned above. I have a different proposal: how about not making doctors be policemen, and how about allowing policemen to deal with actual crime. Legalize drugs (that is, end prohibition)so that the problems associated with the drug laws can be minimized, and let adults decide for themselves what substances they want to ingest. When pain patients fail to treat their pain successfully this way, they can come to their physicians and get the right things done, assuming professional competence. Really, isn't that the best focus of our efforts, rather than more coercion and violence to peoples lives? Also, I'd like to say that I saw the photo of Dr. Calahan in the Times and it looked to me like he has an addiction problem of his own- to food> what makes him think that his addiction is any less dangerous or costly to our society than someone elses. How about sanctions for Macdonald's for selling him all those Big Macs?

As part of the management for pain from CRPS (all four limbs) and avascular necrosis in most long bones, I've probably tempted fate far too many times, and know that I am very lucky.

For instance, I have experienced, on the one hand, how horrible it is to be undertreated for pain; And, on the other hand, I have barely escaped with my life after becoming slowly, imperceptibly toxic on methadone.

I have had two terrible pain management specialists: one did nothing but prescribe very high dose narcotics; the other made his money from procedures (never mind that they were not working, even in the short term of a few hours).

I now have a so-so doctor -- and that works, oddly enough.

Why? Because I have evolved as a pain patient, in part. Not to be snotty, but you cannot expect that to happen with all pain patients.

So what else has helped? It is imperative that there be a PLAN, that there be a physician involved who is taking the long view of things. It's important that patients are educated about pain --attacking pain with different modalities puts less of an emphasis on "pain-killing" via opiates. Finding time now -- when things are not emergent -- to empower patients to use the mind --biofeedback, distraction, NOT catastrophizing -- saves time and resources later, and is crucial to defusing pain "emergencies." [If you believe there is such a thing...]

As a patient, when my pharmaceutical arsenal against pain is filled with a variety of agents, I do much better than in the days when I was told to just swallow more and more narcotics. I take methadone and percocet, daily, but I am taking less than I did five years ago. I take less than is prescribed of the baseline methadone, and never exceed the prescribed amount of breakthrough percocet.

I have learned to respect NSAIDS and know they do the best job on my bone pain. If only I were not prone to gi bleeding!

I have learned that spasms/jerks/tics are now a big part of my CRPS pain, and so baclofen is sometimes the smarter choice than percocet.

I take several antidepressants -- and hell, I don't know if amitriptyline does anything for neuropathic pain, but am told it does, so I toe the line. I am very aware of being depressed, have felt the real difference when off of antidepressants, and consider them part of the anti-pain package! At the moment, I would need to cheer up to be suicidal... but that's another topic.

The most important thing a pain specialist can do for someone with a severe chronic pain condition is to NOT promise total relief. Instead, be honest and promise instead to MANAGE the pain.

I don't think it has been a real advantage for anyone to have "pain" become a diagnosis in and of itself -- because the times when I have had the most trouble came when my pain was being treated as if it were some stand alone thing, and not dependent on some very real disease processes. The context for the pain needs to be in the forefront of everyone's mind.

What absolutely made me want to comment, even rambling as I am, was the statement about seeing patients with back pain enter pain management only to die several years down the road from drug overdoses.

That's a tragedy. That's tragic. Somewhere along the line, and probably quite early on, the context for the pain was dismissed as irrelevant, and it isn't. It never is...

Number one, 8 CMEs for pain theory education for every licensed provider. Period...once in a career is not asking much.Number two, public education in schools on non medical use of opioids and other prescription drugs and their dangers to human health/life and social costs..let's put in some economic principles.Number three, public funds (if there are any around) to encourage the r & d of alternative pain meds that deal with inflammation, hyperalgesia, allodynia.Number four, funds set aside in every health care insurance plan for alternative care such as massage, herbal specialists, acupuncture, ayurveda, that can create alternatives for early non cancer chronic patients.Number five: education in highschools, colleges, medical schools, dental schools, psychology masters/phd programs, chiropractors, etc. in the state of the art knowledge of pain theory and its potential applications...

This is just requires some rationality, sincerity and energy to get all providers to take responsibility for their own education on the "underwear of humanity - pain".

Shadowfax

About me: I am an ER physician and administrator living in the Pacific Northwest. I live with my wife and four kids. Various other interests include Shorin-ryu karate, general aviation, Irish music, Apple computers, and progressive politics. My kids do their best to ensure that I have little time to pursue these hobbies.

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